Fracting tool and fracting system with double-sided

Abstract

The present invention relates to a rupture tool for surgical procedures, and a rupture system comprising the rupture tool and a rupture movement generating device. The rupture tool and system are suitable for the field of traumatology, and are particularly used for creating bone tunnels suitable for correct anatomical reconstruction of tendons and ligaments; for example, for creating bone tunnels in surgery for reconstructing knee anterior cruciate ligament (ACL) and in surgery for repairing shoulder supraspinatus tendons.

Description

[0001] Object of the Invention

[0002] The present invention relates to a rupture tool for surgical operations and a rupture system including the rupture tool and a rupture motion generating device. The rupture tool and the system are used in the field of traumatology, particularly for creating bone tunnels suitable for the correct anatomical reconstruction of tendons and ligaments; for example, for creating bone tunnels in an interventional operation for reconstructing the anterior cruciate ligament (ACL) of the knee joint and in an interventional operation for repairing the supraspinatus tendon of the shoulder joint. Background Art

[0003] One of the most common injuries in the field of traumatology is the tearing of joint tendons and ligaments.

[0004] The most common tendon tear is the rotator cuff tendon tear, mainly the supraspinatus tendon. This injury is the main cause of shoulder joint instability, with an incidence of 20.7% in the general population, and the prevalence increases with age (“Prevalence and risk factors of a rotator cuff tear in the general population”, Yamamoto A et al / J Shoulder Elbow Surg. 2010 Jan; 19(1):116-20).

[0005] In the surgery for reconstructing the supraspinatus tendon, screws are often screwed into the humeral head. These screws are provided with sutures or suture tapes, and the sutures or suture tapes pass through the damaged end of the tendon in order to pull it, reposition it, and fix it in the original insertion area.

[0006] In many cases, a problem that hinders the success of the reconstruction is that the screw with a suture only provides surface compression in the original insertion area of the tendon at the end of the tendon, and this area is reduced by the screw itself, thus hindering the healing process. If the tendon cannot heal, the surgery is insufficient because the surgery aims not only to reposition the tendon in the bone but also to promote the tendon-bone healing process in order to correctly reconstruct the damaged tendon (Castagna et al. 2018, Arthroscopic Transosseous Rotator Cuff Repair).

[0007] In terms of ligaments, the tearing of the cruciate ligaments of the knee joint, mainly the anterior cruciate ligament (ACL) tear, is the most common tear and occurs in patients of all ages.

[0008] In most cases, patients with an ACL tear must undergo surgery, including removing the damaged ACL and replacing it with an implant, and the two ends of the implant are respectively implanted and fixed in the bone tunnels of the tibia and the femur.

[0009] As with tendons, to achieve an anatomically correct ACL reconstruction, a system that restores the original insertion areas must be provided. Unfortunately, with existing techniques, 70% of patients will develop osteoarthritis within 15 to 20 years after surgery.

[0010] To successfully restore the anatomical bone insertion of the original ACL, a solution is currently known that describes an arthroscopic guide that allows the creation of two or more consecutive bone tunnels, which are subsequently connected by a dilator. For example, document US2019 / 0192278 describes an arthroscopic guide that allows the creation of three consecutive bone tunnels, which are subsequently connected by a dilator.

[0011] However, the first problem with this multi-tunnel rupture system is the inability to access the tibia "from inside out", thus preventing the implementation of the "all-inside" anatomical reconstruction technique for the cruciate ligament. The second problem is that when accessing the lateral femoral condyle through the medial portal, a sufficiently lateral femoral bone tunnel cannot be formed, resulting in a loss of the torsional degree relative to the original ACL. The consequences of the inability to fully restore the torsional biomechanics of the original ACL are widely described in the literature: rotational knee instability and mid-term degenerative arthritis.

[0012] However, the first problem with this multi-tunnel rupture system is the inability to access the tibia "from inside out", thus preventing the implementation of the "all-inside" anatomical reconstruction technique for the cruciate ligament. The second problem is that when accessing the lateral femoral condyle through the medial portal, a sufficiently lateral femoral bone tunnel cannot be formed, resulting in a loss of the torsional degree relative to the original ACL. The consequences of the inability to fully restore the torsional biomechanics of the original ACL are widely described in the literature: rotational knee instability and mid-term degenerative arthritis.

[0013] Solving these problems requires creating a bone tunnel for the suture to pass through via minimally invasive surgery and carving a bone shell along the original insertion anatomical area for inserting the damaged end of the tendon and / or for an implant for repair or reconstruction; however, this is not achievable with currently state-of-the-art articulated rupture tools, such as the tools described in documents US W0219US22632 and US9254138.

[0014] These articulated rupture tools in the prior art are used for rupturing tissue in minimally invasive discectomy. Both of the above rupture tools include a rotating drive shaft and a rupture element that is articulated to the rotating drive shaft. However, the solutions described in these two documents both provide single-sided tools with a large number of parts, which increases the manufacturing and assembly costs and does not provide the rigidity required for the rupture tool to cut bone tissue.

[0015] In addition, both of the two rupture tools in the prior art can only sweep one side of the sagittal plane of the rupture tool; the rupture element starts from a linear position where the rupture element is coaxial with the rotating drive shaft of the movement, and then turns to an inclined position where the rupture element forms an angle relative to the drive shaft, but only on one side and cannot form an angle relative to the opposite side.

[0016] In discectomy, the tissue to be ruptured is soft tissue, so a small and lightweight movement drive device (i.e., a micro drill) is used. Therefore, once the rupture tool is introduced into the intervertebral space, only a simple single-sided hinge structure is required to meet the requirements, because the system composed of the rupture tool and the micro drill is lightweight and easy to control and rotate.

[0017] However, in minimally invasive surgical procedures for anatomical reaming of large bones such as the tibia, femur, and humerus, heavier drills are required. In this application scenario, a bilaterally hinged rupture tool can avoid the operational complexity of having to rotate the entire system to achieve bilateral bone cutting.

[0018] Therefore, to address the above problems, there is an urgent need to provide a bilaterally hinged rupture tool and system that have sufficient rigidity to cut bone tissue in large bones, enabling it to first create a straight bone tunnel and then expand its intra-articular exit bilaterally in a simple, reliable, repeatable, and precise manner, thereby forming a bone accommodation structure suitable for the anatomical reconstruction and regeneration of damaged tendon or ligament ends. Summary of the Invention

[0019] The present invention proposes a solution to the foregoing problems through a rupture tool for surgical procedures according to claim 1 and a rupture system for surgical procedures according to claims 15 and 16. The dependent claims define preferred embodiments of the present invention.

[0020] In a first aspect of the invention, the present invention provides a bilateral rupture tool for minimally invasive surgical procedures, comprising:

[0021] A longitudinal element oriented according to a main longitudinal axis, which further comprises:

[0022] A first longitudinal body configured to perform a linear movement along the main longitudinal axis and including a first distal end,

[0023] A second longitudinal body arranged parallel to the first longitudinal body, configured to perform a linear movement along the main longitudinal axis and including a second distal end;

[0024] The rupture assembly further comprises:

[0025] A rupture element, including a rupture axis, and configured to receive and perform a rupture movement about the rupture axis, and for performing an angular movement in a main plane, forming a plurality of angles α with respect to a main longitudinal axis in the main plane, the main plane containing the main longitudinal axis and the rupture axis; and

[0026] A motion transmission element, including a distal portion, wherein the motion transmission element:

[0027] Is disposed inside a longitudinal element, between a first longitudinal body and a second longitudinal body;

[0028] Is connected to the rupture element through the distal portion, and

[0029] Is configured to receive and perform the rupture movement and transmit the rupture movement to the rupture element,

[0030] An articulated connection device, including

[0031] A first section connected to the first distal end of the first longitudinal body;

[0032] A second section connected to the second distal end of the second longitudinal body; and

[0033] A central section including a through hole, through which a rupture assembly passes, and the rupture assembly is fixed inside the through hole;

[0034] Wherein, the articulated connection device is configured to perform an angular movement in the main plane of the rupture tool, such that:

[0035] When the first longitudinal body performs a linear movement in the proximal-distal direction, the second longitudinal body performs a linear movement in the distal-proximal direction, and the rupture element performs an angular movement in the main plane in a first direction, and

[0036] When the first longitudinal body performs a linear movement in the distal-proximal direction, the second longitudinal body performs a linear movement in the proximal-distal direction, and the rupture element performs an angular movement in the main plane in a direction opposite to the first direction.

[0037] The bilateral rupture tool of the present invention can create a bone tunnel suitable for anatomical reconstruction of damaged tendons and / or ligaments. Specifically, the tool can create a bone tunnel with an elongated (e.g., straight, curved or angled) intra-articular exit, whose exit is similar to the original insertion anatomical area, capable of accommodating the reconstructed tendon or ligament, and whose bone depth is sufficient to ensure its regeneration. Thus, a repair conducive to bone integration is achieved.

[0038] In this application document, a tendon should be understood as a connective tissue band for attaching a muscle to a bone, and a ligament should be understood as a connective tissue band for attaching bones to each other.

[0039] In this application document, the proximal end of a tool (or system) element should be understood as the end closer to the subject using the tool. Conversely, the distal end of a tool (or system) element should be understood as the end farther from the subject using the tool. Preferably, the subject or user is a doctor, veterinarian, or medical or veterinary professional.

[0040] First, the tool includes a longitudinal element. "Longitudinal" should be understood as the body being manufactured or placed along its length direction, especially being oriented along the main longitudinal axis.

[0041] The longitudinal element further includes a first longitudinal body and a second longitudinal body. The two longitudinal bodies are arranged in parallel and perform linear motion along the main longitudinal axis respectively. Preferably, the first longitudinal body and the second longitudinal body are in the form of a channel, a catheter, or a semi-cylindrical tube, and the hollow parts of each body face each other.

[0042] Second, the tool includes a rupture assembly. This assembly further includes an interconnected rupture element and a motion transmission element. The connection can be a fixed connection, making the assembly an integral assembly, or can be achieved through an intermediate connection element (such as a bearing). In addition, the connection is established between the distal part of the motion transmission element and the proximal end of the rupture element.

[0043] Throughout the document, a "rupture element" should be understood as any type of element capable of rupturing, milling, cutting, reaming, polishing, compacting, or perforating biological tissue (especially bone tissue).

[0044] In a specific example, the rupture element is a mill, a rupture mill, a drill bit, a blade, a scraper, a file, a vibratory rupture element, or a reciprocating rupture and / or compacting element.

[0045] In another specific example, the rupture element is a compactor, which causes bone densification, which is very important for early weight-bearing, thereby shortening the rehabilitation time required to return to the pre-injury activity level.

[0046] In other more specific examples, the rupture element:

[0047] has a frustum-conical shape with a proximal diameter larger than the distal diameter;

[0048] has a cylindrical geometry;

[0049] is a hybrid element, where the proximal segment is a compacting segment and the distal segment is a rupturing segment;

[0050] The distal cross-section is circular, elliptical, deltoid, polygonal, or corresponds to any other geometry.

[0051] In a specific embodiment, the diameter of the rupture element can be adjusted at will by the user.

[0052] The rupturing element includes a rupturing axis; for example, the axis of rotation about which the element rotates, or the axis of vibration about which the element vibrates. The element is configured to receive and perform a rupturing motion; the rupturing motion is to be understood as the motion that the element is capable of performing such that the element is capable of rupturing human tissue, preferably bone. Examples of rupturing motions include rotational motion, reciprocating motion, and / or vibrational motion about the rupturing axis.

[0053] In the present application, rotational motion is to be understood as the motion in which the rupturing element makes a 360-degree (constant or non-constant) rotation. Vibrational motion is to be understood as the motion in which the rupturing element makes a preferably periodic motion that oscillates about a stable equilibrium position, causing it to move between two end positions.

[0054] Furthermore, the rupturing element is configured to receive and perform an angular motion in a main plane such that the rupturing element gradually forms a plurality of angles α (denoted as α1, α2, etc.) with respect to the main longitudinal axis. Thus, the main plane is to be understood as the plane that contains the main longitudinal axis and the rupturing axis, located at any position of the rupturing axis.

[0055] In order for the rupturing element to be able to perform the above-described rupturing motion, the rupturing assembly further includes a motion transmission element. The motion transmission element is disposed inside the longitudinal element, i.e., between the first longitudinal body and the second longitudinal body. Preferably, both the first longitudinal body and the second longitudinal body are semi-cylindrical tubes, and the motion transmission element is accommodated within the hollow portions of the two semi-cylindrical tubes.

[0056] Preferably, the motion transmission element is flexible. In one example, the flexibility of the motion transmission element stems from the braided tubular structure of the element. In another example, the flexibility of the motion transmission element stems from the tubular structure of the element that includes incisions and / or openings. In another example, the flexibility of the motion transmission element stems from the element that includes a superelastic nitinol braided core and an outer polymer layer.

[0057] Since the motion transmission element is directly or through an intermediate connecting device connected to the rupturing element, the rupturing motion received and performed by the motion transmission element with respect to its rupturing axis is transmitted to the rupturing element, and the rupturing element will perform the rupturing motion with respect to its own rupturing axis.

[0058] Preferably, the motion transmission element is in the form of a rod or an elongated cylinder.

[0059] Finally, the tool includes a hinged connecting device. In this specification, the term "hinged" is to be understood as a device or element that is connected to one or more elements such that these elements maintain a certain degree of freedom of motion with respect to each other; it also refers to a folding element whose constituent parts maintain a certain degree of freedom of motion with respect to each other.

[0060] Thus, the articulated connection device consists of three interconnected segments that form a single component:

[0061] The first segment is connected to the distal end of the first longitudinal body;

[0062] The second segment is connected to the distal end of the second longitudinal body; and

[0063] A central segment located between the first and second segments, including a through-hole through which the rupture assembly passes, and the rupture assembly is fixed to the interior of the through-hole.

[0064] Preferably, the connection between the first segment and the first longitudinal body, and the connection between the second segment and the second longitudinal body, are mechanical connections, such as by hinges. Alternatively, the connection or connections can be flexible, i.e., all elements form an integral assembly, but their connections maintain degrees of freedom.

[0065] The articulated connection device is configured to perform angular movement about the through-hole in the main plane of the tool, and this angular movement is generated by the linear movement of the first and second longitudinal bodies. In this sense:

[0066] On the one hand, when the first longitudinal body performs linear movement in the proximal-distal direction, the first segment of the articulated connection device also moves in the proximal-distal direction. At the same time, the second longitudinal body performs linear movement in the distal-proximal direction, and the second segment of the articulated connection device also moves in the distal-proximal direction. In this way, both segments move in opposite directions around the through-hole of the central part.

[0067] On the other hand, when the first longitudinal body performs linear movement in the distal-proximal direction, the first segment performs distal-proximal movement, and at the same time, the second longitudinal body and the second segment of the articulated connection device perform corresponding linear movement in the proximal-distal direction.

[0068] The purpose of this angular movement is to cause the rupture element to perform angular movement in the main plane relative to the main longitudinal axis. Since the rupture assembly passes through and is fixed inside the through-hole of the connection device, the angular movement of the connection device will cause the angular movement of the rupture element. Specifically, when the first segment performs proximal-distal movement, the rupture element performs angular movement in the first direction (e.g., to the left) on the front surface; while when the second segment performs the proximal-distal movement, the rupture element performs angular movement in the direction opposite to the first direction (e.g., to the right) on the front surface.

[0069] Throughout the document, movement to the left or right, up or down should be understood as seen from the perspective of the user operating the rupture tool.

[0070] First, the bilateral rupture tool of the present invention can, when the rupture element is in the first position, i.e., its rupture axis is coaxial with the main longitudinal axis of the rupture tool, thus creating a straight bone tunnel. Then, when the rupture element is in the second position after a angular movement, the bilateral rupture tool allows the user to widen the intra-articular exit of the bone tunnel, such that the rupture element is oriented along a second longitudinal axis forming an angle α with the main longitudinal axis.

[0071] The geometry of the intra-articular exit will be similar to the geometry of the original anatomical insertion area of the ligament or tendon to be repaired. For example, elongated intra-articular exits with a funnel-shaped and / or rectangular geometry can be carved respectively in the tibial and femoral bone tunnels for repairing the anterior cruciate ligament (ACL) in the knee joint; also, similarly elongated intra-articular exits with a funnel-shaped and / or rectangular geometry can be carved in the humeral bone tunnel for repairing the damaged supraspinatus tendon in the shoulder joint.

[0072] In the first specific example of using the tool to repair the damaged supraspinatus tendon of the rotator cuff, the dimensions of the intra-articular exit of the bone tunnel to be created must allow the insertion of the end of the damaged tendon, which has a thickness of 4 to 5 millimeters and a width of 20 to 25 millimeters at the shoulder tendon height.

[0073] In the second specific example of using the tool to reconstruct the anterior cruciate ligament, the intra-articular exit of the bone tunnel to be created must allow the insertion of fibrous material, which has a thickness between 2 and 4 millimeters and a width between 12 and 18 millimeters.

[0074] The specific measurement ranges provided in the two specific usage examples must be adjusted according to the anatomy of each patient and the final application of the rupture tool. In general use, the rupture tool is suitable for rupturing any connective tissue and / or cartilage tissue and / or bone tissue in medicine or veterinary medicine.

[0075] Advantageously, such anatomical widening created using the tool is very beneficial for tissue healing, which means that the surgery is effective and its results are lasting.

[0076] In another specific usage example, the rupture tool is suitable for creating a space with a selected shape and size during minimally invasive discectomy by effectively rupturing and removing the tissue in the intervertebral disc.

[0077] In a specific usage example, the rupture tool is suitable for rupturing any connective tissue and / or cartilage tissue and / or bone tissue in medicine or veterinary medicine.

[0078] In a specific usage example, the rupture tool is suitable for creating and / or carving all types of tunnels in surgical interventions for reconstructing any connective tissue and / or cartilage tissue and / or bone tissue in medicine or veterinary medicine.

[0079] In one embodiment, the rupture tool is disposable.

[0080] In a specific embodiment, the rupture assembly passes through and is fixed inside the through - hole in the following ways:

[0081] By a rupture element; or

[0082] By a motion - transfer element; or

[0083] Partly by a rupture element and partly by a motion - transfer element; or

[0084] By a bearing installed in the through - hole; or

[0085] By a combination of two or more of the above - mentioned ways.

[0086] In a specific embodiment, the rupture assembly passes through the through - hole and is fixed to the inside of the through - hole by a bushing or a bearing installed in the through - hole.

[0087] The connection between the motion - transfer element and the rupture element can be located proximal to the through - pipe, or distal to the through - pipe, or the connection can be located within the through - pipe.

[0088] In this specific embodiment, although there may be other feasible configurations within the scope of the present invention, various possible configurations between the rupture assembly and the articulated connection device are still envisioned. As described above, the articulated connection device includes a central portion with a through - hole through which the rupture assembly passes and is fixed within the through - hole.

[0089] In one embodiment, the element passing through and fixed to the through - hole is a rupture element that is firmly connected to a motion - transfer element outside the through - hole.

[0090] In one embodiment, the element passing through and fixed to the through - hole is a motion - transfer element that is firmly connected to a rupture element outside the through - hole.

[0091] In one embodiment, the rupture element and the motion - transfer element each partly pass through the through - hole and are fixed within the through - hole. In this case, the connection between the elements is established within the through - hole.

[0092] In this embodiment, although there may be other feasible configurations within the scope of the present invention, various possible configurations between the rupture assembly and the articulated connection device are still considered. As described above, the articulated connection device includes a central portion with a through - hole through which the rupture assembly passes and is fixed within the through - hole.

[0093] In one embodiment, the element passing through and fixed to the through-hole is a rupture element, which is firmly connected to the motion transmission element outside the through-hole or connected to the motion transmission element by a fixing device.

[0094] In one embodiment, the element passing through and fixed to the through-hole is a motion transmission element, which is firmly connected to the motion transmission element outside the through-hole or connected to the rupture element by a fixing device.

[0095] In one embodiment, both the rupture element and the motion transmission element partially pass through the through-hole and are fixed within the through-hole. In this case, the connection between the elements is established within the through-hole.

[0096] In one embodiment, the element passing through and fixed to the through-hole is a bearing, which serves as a fixing device between the motion transmission element and the rupture element.

[0097] In a particular embodiment, the motion transmission element and / or the rupture element is tubular.

[0098] Throughout the document, when the adjective "tubular" refers to an element, it should be understood that the element includes a longitudinal conduit passing through the element.

[0099] In a particular embodiment, the bilateral rupture tool further includes at least a first connection coupling device, which is configured to connect and / or couple the motion transmission element to the rupture motion generating device.

[0100] The bilateral rupture tool can be connected to a rupture motion generating device, for example, a drilling device that can generate a rotational motion. The tool, particularly the motion transmission element, receives the rupture motion from the rupture motion generating device and transmits it to the rupture element.

[0101] Considering that there may be various different types of rupture motion generating devices, this embodiment contemplates the selection of a tool including one or more connection coupling devices, which are configured to connect or couple the motion transmission element to one or more of the devices.

[0102] Advantageously, the tool has greater versatility and can be connected to any commercially available rupture motion generating device.

[0103] In a particular embodiment, the bilateral rupture tool further includes a support body at least partially surrounding a longitudinal element, and a second connection coupling device configured to connect and / or couple the support body to the rupture motion generating device.

[0104] In this embodiment, the tool includes a support body, which is understood as a main body that makes the tool easier to grasp and partially surrounds the longitudinal element. Optionally, the support body can also be connected or coupled to a breaking motion generating device through one or more second connection coupling means.

[0105] Considering that there may be various different types of breaking motion generating devices, this embodiment contemplates the selection of a tool including one or more second connection coupling means configured to connect or couple the support body to one or more of said devices.

[0106] Advantageously, the tool has greater versatility and can be connected to any commercially available breaking motion generating device.

[0107] In a specific embodiment, the bilateral breaking tool further includes a breaking guide configured to guide the longitudinal element from an original position to at least one target position, wherein the breaking guide includes:

[0108] A tubular guide including:

[0109] A longitudinal conduit having a third proximal end and a third distal end; the longitudinal conduit includes a distal appendage located at the third distal end; and

[0110] A striking edge, which is an extended portion of the longitudinal conduit at the proximal end; and

[0111] Wherein, the longitudinal conduit is configured to accommodate the longitudinal element therein, the tubular guide is oriented according to a first longitudinal guide axis; and the striking edge is configured to receive a striking force along the direction of the first longitudinal guide axis; and

[0112] A guiding arch including:

[0113] A proximal arcuate portion including a first coupling means configured to firmly connect and separate the proximal arcuate portion relative to the tubular guide at a plurality of different positions along the tubular guide,

[0114] The distal arcuate portion further includes a distal tip and a distal point, and the first longitudinal guide axis passes through the distal arcuate portion; and

[0115] A second coupling means configured to couple and separate the distal arcuate portion relative to the proximal arcuate portion at a plurality of different positions such that starting from a first position where the tubular guide is oriented according to the first longitudinal guide axis, when the second coupling means is in a position other than the first position according to a second longitudinal guiding axis, it forms an angle β with the first longitudinal axis.

[0116] In the present embodiment, the tool includes a rupture guide for guiding a rupture element and a longitudinal element from a first initial position (wherein the rupture element is coaxial with the main longitudinal axis (for starting to mill a straight bone tunnel)) to at least a first target position (specifically, the rupture element has linearly moved forward and milled a straight bone tunnel). In addition, the rupture guide is also used to guide the rupture element and the longitudinal element from a second initial position (wherein the rupture element is at an angle relative to the main longitudinal axis (the intra-articular exit of the straight bone tunnel has been widened)) to at least a second target position (specifically, the user has moved the rupture tool backward, and the rupture element is at an angle relative to the longitudinal axis (for reverse milling the intra-articular exit of the initially milled straight bone tunnel).

[0117] Advantageously, using the rupture guide can improve the placement accuracy of the rupture tool for milling a bone tunnel at the target anatomical position and improve the practical usability of the tool.

[0118] First, the rupture guide includes at least one tubular guide. The guide further includes the following elements:

[0119] A longitudinal catheter, preferably tubular, having a proximal end and a distal end. The catheter is sized to be able to accommodate a longitudinal element. In addition, the distal end includes a distal appendage (e.g., a peripheral groove), which should be understood as the distal part and is an extension of the longitudinal catheter, and its cross-sectional diameter is smaller than the diameter of the rest of the longitudinal catheter. In a specific embodiment, the distal appendage includes a polyhedral surface.

[0120] A striking edge, which is an extension of the proximal end of the longitudinal catheter. In the present invention, the "striking edge" should be understood as a protruding part of the proximal end of the longitudinal catheter. For example, the striking edge can be a component adhered to the longitudinal assembly or integrated as a single component in the longitudinal assembly.

[0121] The guide is oriented according to the mentioned first longitudinal guide axis, which will coincide with the main longitudinal axis when the longitudinal element is inserted into the rupture guide, and the main longitudinal axis is oriented according to the main longitudinal axis.

[0122] The method of introducing the rupture tool includes the following steps:

[0123] Milling the entire bone tunnel using the rupture tool and the rupture guide;

[0124] Removing the guide arch by holding the rupture tool within the bone tunnel and within the tubular guide; and

[0125] Introducing the distal appendage into the first section of the bone tunnel by striking the striking edge.

[0126] The dimensions of the distal attachment are adapted to be inserted into the first section of the bone tunnel after the bone tunnel has been milled. Its diameter should be such that it can be inserted into the first section of the bone tunnel with a certain degree of tightness and prevent the rest of the longitudinal catheter from being inserted into the bone tunnel. Preferably, the outer diameter of the attachment is substantially equal to or slightly larger than the diameter of the first section of the bone tunnel.

[0127] In order to introduce the attachment into the first section of the bone tunnel, the user must apply a specific impact force to the proximal end of the striking edge in the direction of the first longitudinal guide axis. For example, this force can be applied using a hammer.

[0128] Preferably, the proximal end of the striking edge is substantially flat.

[0129] Advantageously, the force applied to the striking edge ensures that the distal attachment penetrates the first section of the bone tunnel without clearance. This enables the guide to remain in a stable position, thereby improving the accuracy of positioning the longitudinal element when milling the second section of the bone tunnel and enhancing the practical usability of the tool.

[0130] Secondly, the rupture guide includes a guide arch. Thus, the bending element must be understood to include a proximal arcuate portion which in turn comprises a first coupling means that allows the proximal arcuate portion to be firmly connected to the tubular guide and connected at multiple different positions along the tubular guide. The guide arch also includes a distal arcuate portion which ends in a distal tip and contains a distal point through which the first longitudinal guide axis passes. Finally, the guide arch also includes a second coupling means that allows the distal arcuate portion to be connected to the proximal arcuate portion and connected at multiple different positions along the tubular guide.

[0131] When the second coupling means is in one position, the tubular guide is oriented according to the first longitudinal guide axis, which forms a different angle α2 with the orientation of the tubular guide according to the first longitudinal guide axis when the second coupling means is in any other position.

[0132] Preferably, the distal tip of the distal portion is configured to be inserted into the patient's body and thereby fix the rupture guide. In one example, the distal portion has an oval, cylindrical or annular structure, and optionally, the distal tip is pointed.

[0133] Fixing the distal tip in the patient's body can advantageously achieve a more stable guiding position, which increases the placement accuracy of the longitudinal element when milling the bone tunnel in the target anatomical position and enhances the practical usability of the tool.

[0134] In addition, the first coupling device is configured to firmly connect and disconnect the proximal arcuate portion relative to the tubular catheter at a plurality of different positions along the catheter. Advantageously, the first coupling device allows the tubular catheter to be positioned at different locations, providing a high degree of versatility for the ruptured catheter and enabling it to adapt to specific applications (medical or veterinary), specific surgeries, and / or the specific anatomy of the patient. Another additional advantage is that the guiding arch and the tubular catheter can be easily separated, which makes it easier to remove the guiding arch after the longitudinal element is inserted into the tubular catheter and the bone tunnel is dug out.

[0135] A second coupling device between the proximal arcuate portion and the distal arcuate portion allows the guide to be adjusted according to the direction in which the user wishes to carve the first section of the bone tunnel based on their preferences and the anatomy of each patient.

[0136] Widening the intra-articular exit of the bone tunnel requires tilting the rupturing element to both sides of the first longitudinal guiding axis and initiating the rupturing movement.

[0137] In a specific embodiment, the tubular guide further includes a first longitudinal hole and a second longitudinal hole;

[0138] The first longitudinal body further includes a first protrusion; and

[0139] The second longitudinal body further includes a second protrusion;

[0140] wherein the size of the first longitudinal hole is adapted to receive and guide the first protrusion from a proximal position to a distal position and vice versa; and

[0141] the size of the second longitudinal hole is adapted to receive and guide the second protrusion from a proximal position to a distal position and vice versa.

[0142] In this embodiment, the present invention designs two holes on the guide and two protrusions on the longitudinal element, which are respectively located on the first longitudinal body and the second longitudinal body. Each pair of hole-protrusion is used to guide the rupturing element in order to form a straight bone tunnel and carve out the intra-articular exit.

[0143] The sizes of the two holes are adapted to receive and guide the two protrusions of the longitudinal body, enabling them to move from a proximal position (i.e., the position where one of the longitudinal holes receives its corresponding protrusion) to a distal position, where the protrusion passes through the corresponding longitudinal hole and extends all the way to the bottom. Since the longitudinal bodies move in opposite directions, when the protrusion of the first longitudinal body is in the proximal position, the protrusion of the second longitudinal body is in the distal position; and vice versa.

[0144] In addition, each pair of hole-bump can also guide the rupture element during the osteotomy surgery of the bone. Therefore, once a straight bone tunnel is created, the user can move the rupture tool backward in the tubular guide in the distal-proximal direction to widen the intra-articular exit. During the widening process, the activation state of the rupture motion must be maintained.

[0145] When the intra-articular exit opening of the bone tunnel is widened, the rupture guide increases the usability and precision of the rupture tool.

[0146] In a specific embodiment, the distal appendage includes:

[0147] a triangular leaf tip; or

[0148] two tips; or

[0149] a beveled groove; or

[0150] the surface of a polyhedron.

[0151] In this embodiment, different types of distal appendages are provided, although there may be other types that fall within the scope of the present invention.

[0152] In a particular embodiment, the bilateral rupture tool further includes an actuator configured to generate and transmit a linear motion to the first longitudinal body and the second longitudinal body such that the two longitudinal bodies move linearly in opposite directions.

[0153] Therefore, the movements of the two longitudinal bodies are coordinated by the actuator: when one longitudinal body moves in one direction, the other longitudinal body moves linearly in the opposite direction. The two linear movements are simultaneous and opposite-direction movements, both driven by the actuator.

[0154] Advantageously, the actuator allows the user of the rupture tool to adjust the angle of the rupture element at will. In addition, in order for the rupture element to perform an angular movement, the longitudinal bodies of the longitudinal elements must move linearly in opposite directions.

[0155] In this embodiment, widening the bone tunnel using the bilateral rupture tool is achieved by the actuator. The user tilts the rupture element to one side of the first longitudinal guide axis and resects the first widened section of the bone tunnel in reverse. Then, using the actuator again, the user tilts the rupture element in the opposite direction and resects the second widened section of the bone tunnel in reverse.

[0156] Specifically, in different specific embodiments of the rupture tool of the present invention, the rupture element can be located in different positions:

[0157] a) coaxial with the first longitudinal axis (used for resecting a straight bone tunnel in this position);

[0158] b) angled with respect to the first side of the first longitudinal axis; and

[0159] c) angled with respect to the second side of the first longitudinal axis, wherein the second side is opposite to the first side.

[0160] In one embodiment, the first longitudinal body includes a first longitudinal notch configured to cooperate with the actuator; and the second longitudinal body includes a second longitudinal notch configured to cooperate with the actuator;

[0161] wherein, the actuator includes:

[0162] a first rod configured to penetrate and cooperate with the first longitudinal notch;

[0163] a second rod configured to penetrate and cooperate with the second longitudinal notch; and

[0164] an actuation trigger connected to the first rod;

[0165] wherein, the first rod and the second rod are arranged in parallel and connected to each other by two longitudinal portions at their ends, such that:

[0166] when the actuation trigger rotates in the proximal - distal direction with respect to the rotation axis located between the first rod and the second rod,

[0167] the first rod rotates in the proximal - distal direction, thereby causing the first longitudinal body to perform a proximal - distal linear motion;

[0168] the second rod rotates in the distal - proximal direction, thereby causing the second longitudinal body to perform a distal - proximal linear motion;

[0169] when the actuation trigger rotates in the distal - proximal direction with respect to the rotation axis,

[0170] the first rod rotates in the distal - proximal direction, thereby causing the first longitudinal body to perform a distal - proximal linear motion;

[0171] the second rod rotates in the proximal - distal direction, driving the second longitudinal body to perform a proximal - distal linear motion.

[0172] This embodiment describes a first embodiment of an actuator configured to generate linear motion and transmit it to longitudinal elements that mechanically cooperate with it.

[0173] On the one hand, both the first longitudinal body and the second longitudinal body of the longitudinal elements include longitudinal notches; both longitudinal notches are configured to cooperate with the actuator.

[0174] The actuator further includes a first rod and a second rod, each rod sized to pass through and mate with a notch in a longitudinal element. The rods are arranged in parallel and interconnected by two longitudinal members such that the two rods and the two longitudinal members form a quadrilateral. In addition, the actuator includes a manually operable trigger that can be operated by a user and is connected to the first rod.

[0175] When the user operates the actuation trigger, it moves in the proximal-distal direction or the distal-proximal direction. The connection of the trigger to the first rod causes the quadrilateral formed by the rod and the longitudinal portion to rotate about its own axis of rotation, which is located between the first rod and the second rod.

[0176] If the movement described by the trigger is in the proximal-distal direction, the first rod rotates in the proximal-distal direction about the axis of rotation of the quadrilateral, causing the first longitudinal body to move linearly in the proximal-distal direction. In turn, the second rod rotates in the opposite direction (i.e., the distal-proximal direction), causing the second longitudinal body to move linearly in the distal-proximal direction.

[0177] Conversely, if the movement described by the trigger is in the distal-proximal direction, the first rod rotates in the distal-proximal direction about the axis of rotation of the quadrilateral, causing the first longitudinal body to move linearly in the distal-proximal direction. In turn, the second rod rotates in the opposite direction (i.e., the proximal-distal direction), causing the second longitudinal body to move linearly in the proximal-distal direction.

[0178] Advantageously, the mechanism allows the longitudinal bodies of the longitudinal elements to move synchronously in opposite directions with the actuation trigger, thereby causing the rupturing element to move angularly in both directions. In other words, the actuator of the present embodiment successfully converts the rotational movement of the trigger into a linear movement of the longitudinal element through this "slotted hole" or groove geometry.

[0179] In one embodiment, the bilateral rupturing tool further includes positioning and fixing means for the actuator, wherein the positioning and fixing means for the actuator are configured to position and fix the actuator in a plurality of different positions such that for each of said positions, the distance between the first distal end and the second distal end of the two longitudinal bodies is different.

[0180] In this embodiment, it is contemplated that the tool has positioning and fixing means for the actuator, which are configured to position the actuator in different positions and fix the actuator in a selected position.

[0181] Preferably, the positioning means for positioning and fixing the actuator fixes the actuator in three positions:

[0182] 1. A first end position, where the first longitudinal body achieves its maximum proximal - distal movement and the second longitudinal body achieves its maximum distal - proximal movement;

[0183] 2. A second end position, where the first longitudinal body achieves its maximum distal - proximal movement and the second longitudinal body achieves its maximum proximal - distal movement; and

[0184] 3. A neutral position where the two longitudinal bodies are aligned such that the relative distance between their distal ends is substantially zero.

[0185] Alternatively, in addition to the two end positions and the neutral position, the positioning and fixing means for the actuator also allows the actuator to be positioned and fixed at other intermediate positions.

[0186] In a more specific embodiment, the positioning and fixing means for the actuator includes a hole in the support body, the size of which is adapted to accommodate a ball and a spring. The spring is located at the bottom of the hole in the support body such that the spring pushes the ball towards the outside of the hole; in addition, the trigger includes two or more holes, the size of which is adapted to partially accommodate the ball.

[0187] When the hole in the support body faces one of the holes in the trigger, under the push of the spring, the ball will be partially located in the hole of the trigger, thereby fixing its position. This position can be overcome by rotating the trigger so that the ball is again fully located in the hole of the support body until a new position is reached, where the hole in the support body faces another hole in the trigger. Thus, the positioning means can fix different positions of the trigger such that the hole in the support body faces one of the holes in the trigger.

[0188] In one embodiment, the actuator further includes a return spring configured to apply a return force to the first longitudinal body and the second longitudinal body such that the relative movement between the bodies is substantially zero.

[0189] In this embodiment, it is contemplated that all actuators of the foregoing embodiments include a return spring configured to position the longitudinal bodies in the neutral position, i.e., the position where the relative movement between the longitudinal bodies is zero.

[0190] In another embodiment, the first longitudinal body includes a first external thread configured to cooperate with the actuator; and the second longitudinal body includes a second external thread configured to cooperate with the actuator; wherein, the first external thread and the second external thread have opposite thread directions;

[0191] wherein the actuator includes

[0192] a nut, which in turn includes:

[0193] a first internal thread portion that matches the first external thread; and

[0194] A second internal thread portion, which mates with the second external thread; wherein, the thread directions of the first internal thread portion and the second internal thread portion are opposite;

[0195] Wherein, the nut is configured to cooperate with the first longitudinal body and the second longitudinal body such that the assembly operates like a dual-spindle mechanism;

[0196] An actuator controller connected to the nut;

[0197] Wherein,

[0198] When the actuator controller rotates in the thread direction of the first internal thread portion, the first longitudinal body performs a proximal-distal linear motion, and the second longitudinal body performs a distal-proximal linear motion;

[0199] When the actuator controller rotates in the thread direction of the second internal thread portion, the first longitudinal body performs a distal-proximal linear motion, and the second longitudinal body performs a proximal-distal linear motion.

[0200] In this application, the "spindle mechanism" should be understood as an assembly composed of a lead screw and a nut. When the nut is fixed, the rotational motion of the lead screw will cause a linear motion of the lead screw relative to the nut, and vice versa. Therefore, through this system, the rotational motion of the lead screw can be successfully converted into a linear motion of the nut, and vice versa.

[0201] This embodiment employs a "dual-spindle mechanism". On the one hand, both the first longitudinal body and the second longitudinal body include external threads, making them act as spindle screws. The thread directions of the two longitudinal bodies are opposite or relative.

[0202] On the other hand, the actuator includes a nut with two different internal thread portions. The first internal thread portion mates with the external thread of the first longitudinal body, while the second internal thread portion mates with the external thread of the second longitudinal body. Mating should be understood as that the longitudinal body can be screwed onto the thread portion. Additionally, the thread directions of the first internal thread portion and the second internal thread portion are opposite.

[0203] The actuator further includes an actuator controller mounted on the nut. The operation of this controller, i.e., its rotation to one side or the other, will drive the nut itself to rotate. Thus, when the actuator controller rotates, the dual-spindle mechanism starts to operate, causing the longitudinal bodies (which act like spindle lead screws) to linearly move relative to the nut in different directions.

[0204] Therefore, when the actuator controller rotates in the thread direction of the first internal thread portion, the first longitudinal body performs a proximal-distal linear motion, and the second longitudinal body performs a distal-proximal linear motion. Conversely, when the actuator controller rotates in the thread direction of the second internal thread portion, the first longitudinal body performs a distal-proximal linear motion, and the second longitudinal body performs a proximal-distal linear motion.

[0205] In one embodiment, the bilateral rupture tool further includes a suction line connectable to an external suction device for removing tissue.

[0206] In a specific embodiment, the rupture tool includes a suction line connectable to an external suction device for removing damaged tissue. Preferably, both the rupture element and the rupture motion transmission element are hollow structures, each including a distal suction window for suctioning bone powder during bone engraving and / or suctioning soft tissue during tissue rupture or reaming. In a more specific embodiment, the external suction device includes a vacuum system.

[0207] In one embodiment, the first longitudinal body and / or the second longitudinal body is rigid and / or straight.

[0208] In one embodiment, the first longitudinal body and the second longitudinal body are structural elements; that is, they form part of the external structure of the rupture tool to impart a certain resistance and stiffness to it. Preferably, these elements are straight and rigid in order to provide the rupture tool with appropriate stiffness to effectively cut bone tissue.

[0209] Furthermore, a second aspect of the present invention provides a bilateral rupture system for minimally invasive surgery, including:

[0210] A rupture motion generating device configured to generate and execute a rupture motion;

[0211] At least one rupture tool according to any one of the foregoing embodiments, which is at least coupled to the rupture motion generating device through a motion transmission element;

[0212] Wherein, the rupture motion generating device is further configured to transmit the rupture motion to the motion transmission element.

[0213] In an embodiment of this bilateral rupture system, preferably, an actuator is included in the rupture tool itself. The motion transmission element acts similar to a mechanical coupler for transmitting the rupture motion generated by the rupture motion generating device to the rupture tool.

[0214] In this case, the present invention not only considers the bilateral rupture tool, but also the tool together with the rupture motion generating device.

[0215] In one embodiment, the rupture tool of the system is disposable. In another alternative or additional embodiment, at least a part of the rupture motion generating device is disposable.

[0216] The above advantages of the tool can be extended to the system.

[0217] A third aspect of the present invention provides a bilateral rupture system for minimally invasive surgery, comprising:

[0218] A rupture motion generating device configured to generate and execute a rupture motion;

[0219] At least one rupture tool as described in the first aspect of the present invention above, which can be connected to the rupture motion generating device through a motion transmission element and a support; wherein

[0220] The rupture motion generating device further includes an actuator configured to generate a linear motion and transmit it to a first longitudinal body and a second longitudinal body, such that the two longitudinal bodies linearly move in opposite directions when receiving the linear motion from the actuator.

[0221] In this embodiment, the present invention not only considers bilateral rupture tools, but also considers the said tools and the rupture motion generating device.

[0222] In the context of the present invention, when it is not explicitly stated that the actuator is included in the rupture motion generating device, the actuator refers to an element belonging to the rupture tool itself.

[0223] In order to enable the rupture element to perform an angular motion, the longitudinal bodies of the longitudinal elements must linearly move in opposite directions. Therefore, this embodiment contemplates that the rupture motion generating device provides a rupture motion to the motion transmission element, enabling it to transmit the said motion to the rupture element and providing a linear motion to the longitudinal bodies, so that the longitudinal bodies linearly move in opposite directions.

[0224] In one embodiment, the rupture tool of the system is disposable. In another alternative or additional embodiment, at least a part of the rupture motion and linear motion generating device is disposable.

[0225] In one embodiment, all rupture systems of the present invention are integrated systems.

[0226] All advantages obtained from the rupture tool of the first aspect of the present invention are applicable to any rupture system including the said rupture tool.

[0227] All features and / or steps of the methods described in this specification (including the claims, the specification, and the drawings) can be combined in any combination, except for combinations of such mutually exclusive features. BRIEF DESCRIPTION OF THE DRAWINGS

[0228] These and other features and advantages of the present invention will be more clearly shown in the following detailed description of the preferred embodiments, which are given by way of illustrative and non - limiting examples and in conjunction with the drawings.

[0229] Figures 1a to 1eShows different views of a bilateral articulated rupture tool according to an embodiment of the present invention. Specifically, Figure 1d Is an exploded view of the rupture tool when including a first exemplary driver. Figure 1e Shows different connection configurations of the flexible transmission element and the rupture element.

[0230] Figure 2 Shows an exemplary structural configuration of the rupture element according to different embodiments of the present invention.

[0231] Figures 3a to 3d Shows a bilateral articulated rupture tool according to an embodiment of the present invention, which includes a rupture guide.

[0232] Figures 4a to 4c Shows a side cross-sectional view of the tool when the first exemplary driver is in different states.

[0233] Figures 5a to 5c Details the movement process of the rupture element under the action of the first exemplary driver. Figure 5d and Figure 5e Show the overall three-dimensional perspective view and side cross-sectional view of the bilateral articulated rupture tool respectively.

[0234] Figure 6 Details the positioning and fixing structure of the first exemplary driver.

[0235] Figure 7a and Figure 7b In, Figure 7a Is an exploded view of the rupture tool when including a second exemplary driver, Figure 7b Is a side cross-sectional view of the second exemplary driver.

[0236] Figures 8a to 8c Shows a side cross-sectional view of the rupture tool when the second exemplary driver is in different states.

[0237] Figures 9a to 9f Shows two rupture systems for surgical operations, in which the bilateral articulated rupture tool can be connected to an orthopedic drill.

[0238] Figures 10a to 10c In, Figure 10a Shows the cylindrical geometry of a tunnel reverse milled using a conventional unilateral rupture tool, Figure 10b and Figure 10c Show the funnel-shaped bone tunnel geometry respectively milled by the bilateral articulated rupture tool described in the present invention.

[0239] Figures 11a to 11f In, Figure 11aIllustrates the method steps of using the rupture system of the present invention to ream a bone tunnel with an enlarged intra-articular exit opening. Figures 11b to 11f Illustrates a first example of using the system during the repair of the supraspinatus tendon of the shoulder joint.

[0240] Figure 12a Figs. 6 to 12f illustrate the steps of an example of using the rupture system during the repair of the anterior cruciate ligament of the knee joint.

[0241] Figure 13a Figs. 10 to 13c illustrate different implant structural configurations for the anatomical reconstruction of the anterior cruciate ligament of the knee joint. Detailed Description

[0242] Figures 1a to 1c Illustrates an external perspective view of the bilateral rupture tool 100, where Figure 1a the rupture element 130 is in a neutral position, in Figure 1b the rupture element 130 is tilted in one direction, and in Figure 1c the rupture element 130 is tilted in the opposite direction. Figure 1d Illustrates an exploded view of the bilateral rupture tool 100. Figure 1e Illustrates different configurations for connecting the motion transmission element 140 (i.e., the flexible transmission element) to the rupture element 130.

[0243] Figure 1a Illustrates a preferred embodiment of the bilateral rupture tool 100 for minimally invasive surgery, which includes a longitudinal element 120 oriented along the main longitudinal axis 101. The longitudinal element 120 includes a first longitudinal body 121 and a second longitudinal body 122. Preferably, the first longitudinal body 121 and the second longitudinal body 122 are in the form of a channel, a catheter, or a semi-cylindrical tube, and the hollow portions of each body face each other.

[0244] The figure further illustrates that the tool includes an actuator 180 configured to generate and transmit linear motion to the first longitudinal body 121 and the second longitudinal body 122, such that the two longitudinal bodies move linearly in opposite directions. The actuator 180 is only an example, and there may be other types of similar actuators or elements that perform the same function as the actuator in the present invention.

[0245] The figure also illustrates a support body 110 that partially surrounds the longitudinal element 120 and houses the actuator 180 therein, although the support body 110 is optional. In addition, the bilateral rupture tool 100 may optionally include a second connection coupling device 170 configured to connect and / or couple the support body 110 to a rupture motion generating device 200, 200', such as a drilling device.

[0246] Secondly, the fracturing tool includes a fracturing assembly. The fracturing assembly further includes a fracturing element 130 and a motion transfer element 140, which are connected to each other (not visible in Figure 1a ). The connection can be a fixed connection, making the fracturing assembly an integral assembly, or it can be achieved through an intermediate connection element (such as a bearing). In addition, the connection is established between the distal portion 140.1 of the motion transfer element 140 and the proximal end of the fracturing element 130, as shown in Figure 1e .

[0247] The motion transfer element 140 is disposed inside the longitudinal element 120, between the first longitudinal body 121 and the second longitudinal body 122, for receiving and executing the fracturing motion and transferring the fracturing motion to the fracturing element 130. Preferably, the motion transfer element 140 receives the fracturing motion from the fracturing motion generating devices 200, 200' (such as a drilling device).

[0248] In other words, the fracturing element 130 is configured to receive the fracturing motion from the motion transfer element 140 and execute the motion about its fracturing axis 131.

[0249] Furthermore, the fracturing element 130 is configured to receive and execute an angular motion on its front surface, such that the fracturing element 130 gradually forms a plurality of angles α with respect to the main longitudinal axis 101. To enable the fracturing element 130 to execute the fracturing motion, the motion transfer element 140 is disposed inside the longitudinal element 120, that is, between the first longitudinal body 121 and the second longitudinal body 122. Preferably, both the first longitudinal body 121 and the second longitudinal body 122 are semi-cylindrical tubes, and the motion transfer element 140 is received in the hollow portions of the two semi-cylindrical tubes.

[0250] Optionally, the motion transfer element 140 and / or the fracturing element 130 are tubular, as shown in detail in Figure 5d and 5e , which respectively correspond to a three-dimensional view and a side cross-sectional view of an embodiment of the bilateral fracturing tool 100, wherein both the motion transfer element 140 and the fracturing element 130 include corresponding longitudinal ducts 130.2, 140.2 passing through them.

[0251] Optionally, the bilateral fracturing tool 100 further includes at least one first connection coupling device 160, which is configured to connect and / or couple the motion transfer element 140 to a fracturing motion generating device 200 without a second actuator 180', such as a drilling device; or, the motion transfer element 140 can be coupled to a fracturing motion generating device 200' having a second actuator 180', and the latter case is not included in FIG. 1.

[0252] In a preferred embodiment, the bilateral rupture tool 100 includes actuators 180, 190 and at least one first connection coupling device 160 configured to connect and / or couple the motion transfer element 140 to a rupture motion generating device 200 without an actuator, such as a drilling device.

[0253] In another specific embodiment, the bilateral rupture tool 100 does not include actuators 180, 190, but includes connection coupling devices 160, 170 for connecting and / or coupling to a rupture motion generating device 200, which in turn includes actuators 180', 190'.

[0254] Figure 1b and 1c The movement trajectories of the elements of the bilateral rupture tool 100 during use are shown by arrows. On the one hand, the parallel first longitudinal body 121 and the second longitudinal body 122 perform linear movements along the main longitudinal axis 101 respectively. The movement directions depend on the rotation of the trigger 180.1 of the actuator 180 by the user respectively. The operation of the actuator 180 will be explained in detail in the subsequent figures.

[0255] Similarly, the rotation direction of the rupture element 130 depends on the linear movement directions of the first longitudinal body 121 and the second longitudinal body 122.

[0256] Preferably, the motion transfer element 140 is in the form of a rod or an elongated cylinder.

[0257] Finally, the bilateral rupture tool 100 includes a hinged connection device 150, partially visible in Figures 1a - 1c which consists of three interconnected parts forming a single component. The hinged connection device 150 includes: (1) a first section 150.1 connected to the distal end 121.1 of the first longitudinal body 121; (2) a second section 150.2 connected to the distal end 122.1 of the second longitudinal body 122; and (3) a central section 151 located between the first section 150.1 and the second section 150.2, which includes a through hole 151.1 through which a rupture assembly passes, and the rupture assembly is fixed inside the through hole 151.1.

[0258] Preferably, the connection between the first section 150.1 and the first longitudinal body 121, and the connection between the second section 150.2 and the second longitudinal body 122 are mechanical connections, such as by hinges. Alternatively, the connection or these connections can be flexible, that is, all elements form an integral component, but their connections maintain degrees of freedom.

[0259] The articulated connection device 150 is configured to perform an angular movement about a through hole 151.1 in the main plane of the double-sided rupture tool 100, and this angular movement is caused by the linear movement of the first longitudinal body 121 and the second longitudinal body 122. In this sense: on the one hand, when the first longitudinal body 121 performs a linear movement in the proximal-distal direction, the first section 150.1 of the articulated connection device 150 also moves in the proximal-distal direction. At the same time, the second longitudinal body 122 performs a linear movement in the distal-proximal direction, and the second section 150.2 of the articulated connection device 150 also moves in the distal-proximal direction. Thus, the first section 150.1 and the second section 150.2 move in opposite directions around the through hole 151.1 of the central section 151. On the other hand, when the first longitudinal body 121 performs a linear movement in the distal-proximal direction, the first section 150.1 performs a distal-proximal movement. At the same time, when the second longitudinal body 122 performs a linear movement in the proximal-distal direction, the second section 150.2 of the articulated connection device 150 performs a corresponding linear movement in the proximal-distal direction.

[0260] The purpose of this angular movement is to cause the rupture element 130 to perform an angular movement relative to the main longitudinal axis 101 in the main plane to the left or right (or up or down, depending on the positioning of the tool). Since the rupture assembly passes through and is fixed inside the through hole 151.1 of the articulated connection device 150, the angular movement of the articulated connection device 150 causes the angular movement of the rupture element 130. Specifically, when the first section 150.1 performs a proximal-distal movement, the rupture element 130 performs an angular movement in the first direction (such as to the left (or down)) on the front surface; while when the second section 150.2 performs the proximal-distal movement, the rupture element 130 performs an angular movement in the direction opposite to the first direction (such as to the right (or up)) on the front surface.

[0261] Figure 1d Shows all the components of the double-sided rupture tool 100 according to Figures 1a to 1c the illustrated embodiment in an exploded view. It should be noted that the actuator 180 is one of several possible actuators in the context of the present invention and is shown only as an example.

[0262] In Figures 1a to 1d it is also possible to see a reference ring 102 surrounding the longitudinal element 120, and this reference ring 102 can move along the longitudinal element 120. This reference ring 102 is entirely optional and is used to provide a reference for the user using the double-sided rupture tool 100, especially for informing the user of the depth of reverse milling.

[0263] Figure 1eShows in detail different configuration ways between the articulated connection device 150 and the rupture assembly. The rupture assembly passes through and is fixed inside the through-hole 151.1 based on one of the following ways: (1) Based on the rupture element 130, which is connected to the motion transfer element 140 outside the through-hole 151.1; (2) Based on the motion transfer element 140, which is connected to the rupture element 130 located outside the through-hole 151.1; (3) Partly based on the rupture element 130 and partly based on the motion transfer element 140, such that in this case the connection between the rupture element 130 and the motion transfer element 140 is established inside the through-hole 151.1.

[0264] In all these examples, the rupture assembly passes through the through-hole 151.1 and is fixed inside the through-hole 151.1 by a bushing or bearing installed in the through-hole 151.1.

[0265] In one embodiment, the bilateral rupture tool 100 further includes a suction line that can be connected to an external suction device for removing tissue. Preferably, the rupture element 130 is tubular and includes a distal suction window for sucking bone powder during bone engraving and / or sucking soft tissue during tissue rupture or reaming. In a more specific embodiment, the external suction device includes a vacuum system.

[0266] Figure 2 Shows an exemplary structure of the rupture element 130 according to different embodiments of the present invention.

[0267] Figures 3a to 3d Shows a bilateral rupture tool 100 according to an embodiment of the present invention, wherein the bilateral rupture tool 100 includes a rupture guide 300, which is configured to guide the longitudinal element 120 from an original position to at least one target position.

[0268] First, the rupture guide 300 includes at least one tubular guide 310. The tubular guide 310 further includes the following elements: (1) A longitudinal conduit 311, preferably tubular, which has a third proximal end 311.1 and a third distal end 311.2. The longitudinal conduit 311 is sized to accommodate the longitudinal element 120. The third distal end 311.2 also includes a distal appendage 311.3, such as an outer peripheral groove, which is an extension of the longitudinal conduit 311 and has a cross-sectional diameter smaller than the diameter of the rest of the longitudinal conduit 311; (2) A striking edge 312, which is an extension of the longitudinal conduit 311 at the third proximal end 311.1.

[0269] The tubular guide 310 is oriented according to a first longitudinal guide axis 301, which coincides with the main longitudinal axis 101. When the longitudinal element 120 is inserted into the rupture guide 300, the longitudinal element 120 is oriented according to the main longitudinal axis 101.

[0270] The size of the distal appendage 311.2 is adapted to be inserted into the first segment of the bone tunnel after the cutting is completed. Some examples of the distal appendage 311.3 include a triangular leaf-shaped tip, two tips, a beveled groove, or a polyhedral surface.

[0271] In order to introduce the distal appendage 311.2 into the first segment of the bone tunnel, the user must apply a specific striking force at the proximal end of the striking edge 312 in the direction of the first longitudinal guide axis 301.

[0272] Preferably, the proximal end of the striking edge 312 is substantially flat, as can be seen in these figures.

[0273] Secondly, the rupture guide 300 includes a guide arch 320, which includes a proximal arcuate portion 321. The proximal arcuate portion 321 in turn includes a first coupling device 330, which enables the proximal arcuate portion 321 to be firmly connected to a plurality of different positions on the tubular guide 310. The guide arch 320 also includes a distal arcuate portion 322, which terminates at a distal tip 322.1 and includes a distal point 322.2 through which the first longitudinal guide axis 301 passes. Finally, the guide arch includes a second coupling device 340, which enables the distal arcuate portion 322 to be connected and separated from the proximal arcuate portion 321 at a plurality of different positions.

[0274] Starting from the first position where the tubular guide 320 is oriented according to the first longitudinal guide axis 301, when the second coupling device 340 is in a position other than the first position according to the second longitudinal guide axis 301.1, it forms an angle β with the first longitudinal guide axis 301.

[0275] The distal tip 322.1 is configured to be introduced into the patient's body and thus fix the rupture guide. The distal tip is sharp in these specific figures.

[0276] The first coupling device 330 is used to firmly connect and separate the proximal arcuate portion 321 at a plurality of different positions on the tubular guide 310 along the guide. These elements are in a separated state in Figure 3a and in a connected state in Figure 3b .

[0277] In addition, Figure 3c shows the rupture guide 300 for the longitudinal element 120 of the bilateral rupture tool 100 to be introduced. Figure 3d shows the tool 100 when the longitudinal element 120 has been fully introduced to the bottom of the rupture guide 300.

[0278] Finally, although optional, Figures 3a to 3dThe display tubular guide 310 further includes a first longitudinal hole 313 and a second longitudinal hole 313', which are sized to accommodate a first protrusion 121.3 in the first longitudinal body 121 and a second protrusion 122.3 in the second longitudinal body 122. Thus, the first longitudinal hole 313 and the second longitudinal hole 313' can guide the first protrusion 121.3 and the second protrusion 122.3 from a proximal position to a distal position and vice versa.

[0279] Return to Figure 1d , which shows an exploded view of the bilateral rupture tool 100 including the first exemplary actuator 180. Figures 4a to 4c A side cross-sectional view of the bilateral rupture tool 100 in different states of the actuator 180 is shown. The actuator 180 is configured to generate and transmit linear motion to the first longitudinal body 121 and the second longitudinal body 122 such that the first longitudinal body 121 and the second longitudinal body 122 linearly move in opposite directions.

[0280] For this purpose, the first longitudinal body 121 includes a first longitudinal notch 121.4 for mating with the actuator 180, and the second longitudinal body 122 includes a second longitudinal notch 122.4 for mating with the actuator 180. These notches can be seen in detail in Figure 1d , which shows the bilateral rupture tool equipped with the actuator 180 in an exploded view.

[0281] Relatively speaking, the actuator 180 includes: (1) a first rod 181 configured to penetrate and mate with the first longitudinal notch 121.4; (2) a second rod 182 configured to penetrate and mate with the second longitudinal notch 122.4; (3) an actuator trigger 180.1 connected to the first rod 181.

[0282] The first rod 181 and the second rod 182 are arranged in parallel and are connected to each other by two longitudinal members 183 and 184 at their two ends, thus jointly forming a quadrilateral. And the actuator trigger 180.1 is a manual trigger that can be operated by the user.

[0283] When the user operates the actuator trigger 180.1, it can perform a rotational motion in the proximal-distal direction or the distal-proximal direction. The connection of the trigger 180.1 to the first rod 181 causes the quadrilateral formed by the first rod 181, the second rod 182, and the two longitudinal parts 183 and 184 to rotate relative to its own rotation axis 185, which is located between the first rod 181 and the second rod 182.

[0284] Figure 4aAn example is shown where the direction of movement of the trigger 180.1 is proximal - distal. Along with this movement, the first rod 181 rotates in the proximal - distal direction relative to the rotational axis 185 of the quadrilateral, causing the first longitudinal body 121 to move linearly in the proximal - distal direction. In turn, the second rod 182 rotates in the opposite direction (i.e., distal - proximal direction), causing the second longitudinal body 122 to move linearly in the distal - proximal direction. As shown, these movements of the first longitudinal body 121 and the second longitudinal body 122 cause the rupture element 130 to move angularly in a first direction, in this case downward or to the left (depending on the orientation of the rupture tool).

[0285] Figure 4b An example is shown where the direction of movement of the trigger 180.1 is distal - proximal. Along with this movement, the first rod 181 rotates in the distal - proximal direction relative to the rotational axis 185 of the quadrilateral, causing the first longitudinal body 121 to move linearly in the distal - proximal direction. In turn, the second rod 182 rotates in the opposite direction, i.e., proximal - distal direction, causing the second longitudinal body 122 to move linearly in the proximal - distal direction. As shown, these movements of the first longitudinal body 121 and the second longitudinal body 122 cause the rupture element 130 to move angularly in a direction opposite to the first direction, in this case upward or to the right (depending on the orientation of the rupture tool).

[0286] Figure 4c An example is shown where the trigger 180.1 does not move in any direction, i.e., it is in an intermediate or neutral position. In this case, there is no linear movement of the first longitudinal body 121 and the second longitudinal body 122, so the rupture element 130 remains in the neutral position, coaxial with the longitudinal element 120.

[0287] Finally, it should be noted that Figures 4a - 4c The rupture movement received by the movement transmission element 140 is also shown, in this case a rotational movement, and the movement transmission element 140 transmits this movement to the rupture element 130.

[0288] Figures 5a - 5c Details are shown of the movement of the rupture element 130 under the action of the actuator 180 according to Figures 4a - 4c the three states described respectively.

[0289] Figures 5a - 5cSpecific exemplary positioning and fixing devices for the first exemplary actuator 180 are shown in detail. In this example and other possible embodiments, these positioning and fixing devices for the actuator 180 are configured to position and fix the actuator 180 at a plurality of different positions such that the distance between the first distal end 121.1 of the first longitudinal body 121 and the second distal end 122.1 of the second longitudinal body 122 is different at each of said positions.

[0290] Preferably, the positioning and fixing devices for positioning and fixing the actuator position and fix the actuator 180 at at least three positions: (1) a first end position where the first longitudinal body 121 achieves its maximum proximal - distal movement and the second longitudinal body 122 achieves its maximum distal - proximal movement; (2) a second end position where the first longitudinal body 121 achieves its maximum distal - proximal movement and the second longitudinal body 122 achieves its maximum proximal - distal movement; (3) a neutral position where the first longitudinal body 121 and the second longitudinal body 122 are aligned such that the relative distance between the first distal end 121.1 and the second distal end 122.2 is substantially zero.

[0291] Optionally, in addition to the two end positions and the neutral position, the positioning and fixing devices of the actuator also allow the actuator 180 to be positioned and fixed at other intermediate positions.

[0292] In Figure 6 In the specific example shown, the positioning and fixing device of the actuator 180 includes a hole 195.3 in the support body 110, the size of which is adapted to accommodate the ball 195.1 and the spring 195.2. The spring 195.2 is located at the bottom of the hole 195.3 of the support body 110 such that the spring 195.2 pushes the ball 195.3 towards the outside of the hole 195.3; the trigger 180.1 also includes two or more holes 195.4, the size of which is adapted to partially accommodate the ball 195.1.

[0293] When the hole 195.3 of the support body 110 faces one of the holes 195.4 of the trigger 180.1, the ball 195.3 is pushed by the spring 195.2 and is partially located in the hole of the trigger 180.1, being fixed at this position. This position can be overcome by rotating the trigger 180.1 such that the ball 195.1 is again fully accommodated within the hole 195.3 of the support body 110 until a new position is reached where the hole 195.3 of the support body 110 faces a new hole 195.4 of the trigger 180.1, thereby allowing the positioning device to fix different positions of the trigger 180.1 where the hole 195.4 of the support body 110 faces one of the holes 195.4 of the trigger 180.1.

[0294] In one embodiment, the actuator 180 further includes a return spring configured to apply a return force to the first longitudinal body 121 and the second longitudinal body 122 such that the relative movement between the first longitudinal body 121 and the second longitudinal body 122 is substantially zero. Thus, the return spring is configured to position the first longitudinal body 121 and the second longitudinal body 122 in a neutral position, i.e., a position where neither longitudinal body is in a forward or backward position relative to the other longitudinal body.

[0295] Figure 7a An exploded view of the bilateral rupture tool 100 incorporating the second exemplary actuator 190 is shown. Figure 7b A side cross-sectional view of the second exemplary actuator 190 is shown.

[0296] The actuator 190 is configured to generate linear motion and transmit it to the first longitudinal body 121 and the second longitudinal body 122 such that the first longitudinal body 121 and the second longitudinal body 122 linearly move in opposite directions.

[0297] To this end, the first longitudinal body 121 includes a first external thread 191 for mating with the actuator 190; the second longitudinal body 122 includes a second external thread 192 for mating with the actuator 190. The thread directions of the first external thread 191 and the second external thread 192 are opposite, as can be viewed in detail in Figure 7a which shows, in an exploded view, the bilateral rupture tool 100 with the actuator 190.

[0298] The actuator 190 includes a nut 193 which in turn includes a first internal thread portion 193.1 that mates with the first external thread 191 and a second internal thread portion 193.2 that mates with the second external thread 192. The thread directions of the first internal thread portion 193.1 and the second internal thread portion 193.2 are opposite, and the nut 193 is configured to cooperate with the first longitudinal body 121 and the second longitudinal body 122 such that the assembly operates like a double-spindle mechanism.

[0299] On the one hand, the first external thread 191 of the first longitudinal body 121 and the second external thread 192 of the second longitudinal body 122 cause these bodies to act as main spindle screws. On the other hand, the first internal thread portion 193.1 and the second internal thread portion 193.2 of the nut 193 interact with the main spindle screws such that the same nut 193 performs a dual function. Since the thread directions of the first internal thread portion 193.1 and the second internal thread portion 193.2 are opposite, when the nut 193 rotates, one main spindle screw linearly moves in one direction and the other main spindle screw linearly moves in the opposite direction, as described below.

[0300] The actuator 190 further includes an actuator controller 194 connected to the nut 193. The operation of the actuator controller 194, i.e., its rotation to one side or the other, causes the nut 193 itself to rotate. Thus, when the actuator controller 194 rotates, the dual-spindle mechanism starts to operate, causing the first longitudinal body 121 and the second longitudinal body 122, which act like a spindle lead screw, to linearly move in opposite directions.

[0301] Figures 8a - 8c A side cross-sectional view of the bilateral rupture tool 100 is shown when the second exemplary actuator 190 is in different states.

[0302] Figure 8a An example is shown in which the actuator controller 194 rotates in the threading direction of the first internal thread portion 193.1. This causes the first longitudinal body 121 to perform a proximal-distal linear motion and the second longitudinal body 122 to perform a distal-proximal linear motion. As Figure 8a shown, these motions of the first longitudinal body 121 and the second longitudinal body 122 cause the rupture element 130 to perform an angular motion in the first direction, which is downward or leftward in this example (depending on how the rupture tool is positioned).

[0303] Conversely, as Figure 8b shown, when the actuator controller 194 rotates in the threading direction of the second internal thread portion 193.2, the first longitudinal body 121 performs a distal-proximal linear motion and the second longitudinal body 122 performs a proximal-distal linear motion. As Figure 8b shown, these motions of the first longitudinal body 121 and the second longitudinal body 122 cause the rupture element 130 to perform an angular motion in the direction opposite to the first direction, which is upward or rightward in this example (depending on how the rupture tool is positioned).

[0304] Figure 8c An example is shown in which the actuator controller 194 does not move in any direction, i.e., the actuator controller is in an intermediate position or a neutral position. In this case, the first longitudinal body 121 and the second longitudinal body 122 do not linearly move, so the rupture element 130 remains in the neutral position and is coaxial with the longitudinal element 120.

[0305] Advantageously, the actuator 190 fixes different angular positions through a reverse spindle mechanism without the need for additional positioning devices.

[0306] Finally, it should be noted that Figures 8a - 8c the rupture motion received by the motion transmission element 140 is shown simultaneously. In this example, it is a rotational motion, and the motion transmission element 140 transmits this motion to the rupture element 130.

[0307] Figures 9a - 9fIllustrated are embodiments of two rupture systems for surgical operations, namely a first rupture system 400 and a second rupture system 500. Specifically, Figures 9a - 9d refers to the first rupture system 400, while Figures 9e - 9f refers to the second rupture system 500. The first rupture system 400 includes a rupture motion generating device 200 and a bilateral rupture tool 100 having an actuator according to any of the foregoing embodiments. In the first rupture system 400, the bilateral rupture tool 100 includes actuators 180, 190.

[0308] In addition, the second rupture system 500 includes a rupture motion generating device 200', which in turn includes actuators 180', 190', so in this specific embodiment, the rupture tool does not include an actuator; wherein, the linear motion of the first longitudinal body 121 and the second longitudinal body 122 in opposite linear directions is generated and transmitted by the actuators 180', 190' of the rupture motion generating device 200'.

[0309] The rupture motion generating devices 200, 200' shown in the figures are drilling devices, which are configured to generate and execute a rupture motion, which is a rotational motion in this example. In addition, they are also configured to transmit the rupture motion to the motion transmission element 140.

[0310] Specifically, Figure 9a A side view of the first rupture system 400 is shown, in which the bilateral rupture tool 100 is separated from the rupture motion generating device 200.

[0311] Figure 9b A side view of the first rupture system 400 is shown, in which the bilateral rupture tool 100 is connected to the rupture motion generating device 200 in a non-activated state. This connection is established between the rupture motion generating device 200 and the motion transmission element 140 through a first connection coupling device 160.

[0312] Figure 9c A side view of the first rupture system 400 is shown, in which the bilateral rupture tool 100 is connected to the rupture motion generating device 200, which is in a non-activated state similar to the above figure. In this case, the connection between the rupture motion generating device 200 and the motion transmission element 140 is established through a first connection coupling device 160, and the connection between the rupture motion generating device 200 and the support 110 is established through a second connection coupling device 170.

[0313] Figure 9d The above-mentioned second connection coupling device 170 is shown in detail.

[0314] Figure 9eA side view of a second rupture system 500 is shown, which system includes a rupture motion generating device 200' and a bilateral rupture tool 100. In Figure 9e it, the rupture motion generating device 200' is shown separated from the rupture tool 100.

[0315] Figure 9f A second rupture system 500 for surgical operations is shown, including: (1) a rupture motion generating device 200', configured to generate and execute a rupture motion, the rupture motion generating device 200' being an actuator 190'; (2) at least one bilateral rupture tool 100 without an actuator, which can be connected to the rupture motion generating device 200' through a motion transmission element 140 and a support 110; wherein the rupture motion generating device 200' is further configured to transmit the rupture motion to the motion transmission element 140 and transmit a linear motion to a first longitudinal body 121 and a second longitudinal body 122 through the actuator 190'. The linear motion direction of the first longitudinal body 121 is opposite to that of the second longitudinal body 122.

[0316] Figure 9f In the example shown, Figure 9e the connection positions of the second rupture system 500 in Figure 9f are shown, where the bilateral rupture tool 100 is connected to the rupture motion generating device 200'. The connection between the rupture motion generating device 200' and the motion transmission element 140 is established through a first connection coupling device 160, and the connection between the rupture motion generating device 200' and the support 110 is established through a second connection coupling device 160. In

[0317] In a specific example, the rupture motion generating device 200' includes mechanical and / or electronic devices that can be adjusted at will by the user.

[0318] In a specific embodiment, the first rupture system 400 and the second rupture system 500 include a disposable bilateral rupture tool 100.

[0319] In another specific embodiment, the rupture system includes a bilateral rupture tool 100 and a rupture motion and linear motion generating device 200 or a rupture motion generating device 200', which are disposable except for their motors and batteries.

[0320] Figure 10a The prior art of reverse reaming of a bone tunnel using a rupture tool known in the prior art is shown, which rupture tool has a single rotation axis coinciding with the rupture axis: reverse reaming only provides a cylindrical widening of the first bone tunnel.

[0321] Figure 10b Shows a bone tunnel created and widened using the bilateral fracture tool 100 of the present invention.

[0322] It should be noted that the specific embodiments of the bilateral fracture tool 100 illustrate the advantages of the present invention over fracture tools available in the prior art, and these advantages include the following: (1) fewer parts, thus lower manufacturing and assembly costs; (2) greater rigidity of the components, enabling the carving of bone tissue.

[0323] A surgical method using the fracture system of the present invention.

[0324] In a fourth aspect of the invention that is complementary to the first aspect of the invention, the present invention provides a method for carving a bone tunnel with a widened intra-articular exit in a human or animal body during connective tissue repair. The method is Figure 11a illustrated in the form of a flowchart.

[0325] The method includes the following steps:

[0326] a) Provide a set of fracture systems 400, 500, which includes the bilateral fracture tool 100 of the present invention;

[0327] b) When the fracture element 130 is in a neutral or non-angled position relative to the main longitudinal axis 101, that is, in a state where the main longitudinal axis 101 is coaxial with the fracture axis 131, activate the fracture systems 400, 500 to form an entrance in the outer cortical bone of the bone to be carved and an exit in the inner cortical bone, thereby carving a straight bone tunnel;

[0328] c) By deflecting the fracture element 130 relative to the main longitudinal axis 101 in a first direction, use the fracture tool 100 to carve the first widened section of the bone tunnel;

[0329] d) (Optional) Move the bilateral fracture tool 100 backward for reverse carving to continue carving the first widened section of the bone tunnel;

[0330] e) By deflecting the fracture element 130 relative to the main longitudinal axis 101 in a direction opposite to the first direction, carve the second widened section of the bone tunnel;

[0331] f) (Optional) Move the fracture tool 100 backward for reverse carving to continue carving the second widened section of the bone tunnel;

[0332] g) Reposition the fracture element 130 to a neutral or non-angled position relative to the main longitudinal axis 101, where the main longitudinal axis 101 is coaxial with the fracture axis 131;

[0333] h) Removing the bilateral disrupting tool 100 from the anatomically widened bone tunnel.

[0334] Throughout the description, “reverse scoring” is understood to be the action of moving the disrupting element 130 backward from a first distal position in the bone tunnel to a second proximal position in the bone tunnel, such that by this action the bone tunnel segment through which the disrupting element 130 passes is widened.

[0335] In this example, in step c, the angle between the main longitudinal axis 101 and the rupture axis 131 is defined as α1, which defines the first widening section of the bone tunnel. In addition, in step e, the angle between the main longitudinal axis 101 and the rupture axis 131 is defined as α2.

[0336] In order to perform the method of this embodiment, the user may additionally provide a rupture motion generating device 200, 200'.

[0337] In other specific embodiments, the above method may be performed without any optional steps d or f, or may not include any of the steps.

[0338] In another specific method, a unilateral articulated rupturing tool having sufficient rigidity to cut bone tissue may be used in step a. In this specific method, the change in the angular orientation of the rupturing element 130 relative to the main longitudinal axis 101 in step e is replaced by the joint rotation of the unilateral articulated rupturing tool and the rupturing motion generating device 200, 200'. This joint rotation requires high technical requirements of the operator, requires repeated practice, and will reduce the accuracy of the bone tunnel cutting method and may even cause complications. Therefore, the method is preferably performed using the bilateral rupturing system 400, 500 of the present invention designed specifically for this task.

[0339] First example of using the Rupture System: repairing the supraspinatus tendon in the shoulder joint.

[0340] In a first example of use, the connective tissue being repaired (ie, the aforementioned method) is the supraspinatus tendon of the shoulder joint.

[0341] Figure 11b Details showing different parts of the bone tunnel carved into the greater tuberosity of the humerus:

[0342] 1) Lateral and frontal views of the straight bone tunnel 1.

[0343] 2) Side, front and perspective views of the complete bone tunnel (1-3), wherein the exit holes (2, 3) within the joint are anatomically widened by the rupture system 400, 500 of the present invention.

[0344] Figure 11cShows a preferred and more specific embodiment, in which the rupture systems 400, 500 used in the method include a rupture tool 100, which in turn includes a rupture guide 300.

[0345] In the method embodiment, step b includes the following sub-steps:

[0346] b1) Insert the distal tip 322.1 of the distal arcuate portion 322 of the guiding arch 320 of the rupture guide 300 into the patient's body, and position the distal tip 322.1 at approximately the central position of the original insertion footprint;

[0347] b2) Align the guiding arch 320 parallel to the coronal plane, and position the distal end of the tubular guide 310 of the rupture guide 300 in the outer cortex of the bone to be milled, at a distance between approximately 15 and 25 millimeters from the greater tubercle;

[0348] b3) Use a drill bit with a laser depth marker to mill a straight tunnel in the bone;

[0349] b4) Remove the drill bit and apply an impact force to the striking edge 312 of the tubular guide 310, such that the distal appendage 311.3 of the tubular guide 310 penetrates the straight tunnel.

[0350] In other words, in this embodiment, the bone tunnel is fully milled (step b3), and the bilateral rupture tool 100 is left inside the bone tunnel and the tubular guide 310. The guiding arch 320 is removed and a force is applied to the striking edge 312 in order to insert the distal tip 322.1 of the tubular guide 310 into the bone tunnel.

[0351] Figure 11d Shows a musculoskeletal diagram of a bone tunnel (1 - 3) milled with one of the rupture systems 400, 500 of the present invention, and the insertion of a graft for repairing the supraspinatus tendon of the shoulder joint.

[0352] In a specific example of repairing a damaged supraspinatus tendon of the rotator cuff, the intra-articular outlet dimensions of the bone tunnel to be created are adapted to insert the end of the damaged tendon, the thickness of which at the shoulder tendon height should be between 4 and 5 millimeters, and the width should be between 20 and 25 millimeters. However, the specific measurement ranges provided in the foregoing example must be adjusted according to the specific anatomy and the ultimate application of the rupture tool used, which is generally suitable for rupturing any connective tissue and / or cartilage tissue and / or bone tissue in medicine or veterinary medicine.

[0353] Once an inclined bone tunnel has been created using any of the rupture systems 400, 500 of the present invention and the intra-articular outlet (2 - 3) has been widened into a fan shape or a funnel shape, the end of the supraspinatus tendon to be repaired can be sutured, and the suture tape can be passed through the widened inclined bone tunnel (1 - 3), for example, using a curved suture passer.Figure 11d The tendon end that has passed through the anatomically widened opening of the bone tunnel and the suture tape emerging from the bone tunnel are shown in the lower left. Figure 11d The suture tape fixed by a cortical fixation device (such as the device described in European Patent Application EP3897455 A1) is shown in the lower right.

[0354] Figure 11e The repair process of a partial supraspinatus tendon rupture is shown. This repair process uses the bone tunnel created by any of the rupture systems 400, 500 of the present invention, and the tendon end is passed through the anatomically widened opening of the bone tunnel using the suture tape 20. In the lower right of the figure, the suture tape 20 is fixed by a cortical fixation device (such as the device described in European Patent Application EP3897455 A1).

[0355] Figure 11f A schematic diagram showing the method steps for repairing a complete rupture of the supraspinatus tendon is shown. This method requires creating an anatomically widened bone tunnel using any of the rupture systems 400, 500 of the present invention, and passing the end of the reinforcing tissue 30 through the anatomically widened opening of the bone tunnel using the reinforcing tissue 30 and the suture tape 20. In a specific embodiment, the reinforcing tissue 30 is acellular dermal tissue. In another specific embodiment, the reinforcing tissue 30 comprises biodegradable biopolymer fibers. In another specific embodiment, the reinforcing tissue 30 comprises a bioabsorbable poly(lactic-co-glycolic acid) (PLGA) oriented microfiber scaffold.

[0356] Given that the reported failure rate of complete rupture of the supraspinatus tendon is as high as 68% (Jost B, Pfirrmann CWA, Gerber C. Clinical results after structural failure of rotator cuff repair. J Bone Joint Surg Am 2000; 82: 304-14.), in all cases, the goal is to achieve vascular reconstruction of the tendon end through bone integration of the reinforcing tissue 30.

[0357] A second example of using the rupture system: Repair of the anterior cruciate ligament of the knee joint.

[0358] In the second application example, the connective tissue to be repaired is the cruciate ligament of the knee joint. Figure 12a Shows Figure 11a the method steps described in

[0359] 1. Point 1 shows a straight bone tunnel 4 formed in the tibia using the rupture system 400, 500 of the present invention, with its entrance at the outer bone cortex of the bone and its exit at the inner bone cortex of the bone. In this step, the rupture axis 131 of the rupture element 130 remains coaxial with the main longitudinal axis 101 of the rupture tool 100;

[0360] 2. Point 2 shows how the rupture element 130 forms an angle with respect to the main longitudinal axis 101 of the rupture tool 100 in a first direction, thereby cutting out a first widened section 5 of the intra-articular exit opening of the straight bone tunnel 4.

[0361] 3. Point 3 shows how the rupture element 130 is tilted with respect to the main longitudinal axis 101 of the bilateral rupture tool 100 in a direction opposite to the first direction, thereby cutting out a second widened section 6 of the intra-articular exit opening of the straight bone tunnel 1.

[0362] After these operations, the rupture axis 131 of the rupture element 130 will move to a position where the rupture axis 131 is coaxial with the main longitudinal axis 101 of the bilateral rupture tool 100, that is, move to the neutral position; finally, the bilateral rupture tool 100 will be removed from the straight bone tunnel 4 together with the first widened section 5 and the second widened section 6.

[0363] Figure 12b The straight bone tunnel 4 cut in the tibia is shown in detail, which has a first widened section 5 and a second widened section 6:

[0364] 1) Perspective view of the straight bone tunnel 4.

[0365] 2) Perspective view of the straight bone tunnel 4 with the first widened section 5 cut out by the bilateral rupture tool 100 of the present invention.

[0366] 3) Perspective view of the straight bone tunnel 4 with the first widened section 5 and the second widened section 6 cut by the bilateral rupture tool 100 of the present invention.

[0367] Figure 12c The steps of performing the foregoing method on the femur are shown:

[0368] 1. Point 1 shows the straight bone tunnel 4 formed in the femur by using the rupture systems 400, 500 of the present invention, the entrance of which is located in the outer cortex of the bone and the exit is located in the inner cortex of the bone. In this step, the rupture axis 131 of the rupture element 130 remains coaxial with the main longitudinal axis 101 of the rupture tool 100;

[0369] 2. Point 2 shows how the rupture element 130 forms an angle with respect to the main longitudinal axis 101 of the rupture tool 100 in a first direction, thereby cutting out a first widened section 5 of the intra-articular exit opening of the straight bone tunnel 4, which is defined by the angle α1;

[0370] 3. Point 3 shows how the rupture element 130 is tilted with respect to the main longitudinal axis 101 of the bilateral rupture tool 100 in a direction opposite to the first direction, thereby cutting out a second widened section 6 of the intra-articular exit hole of the straight bone tunnel 1, which is defined by the angle α2;

[0371] 4. Point 4 shows a side view of the straight bone tunnel 4 milled in the femur, having a first widened section 5 and a second widened section 6.

[0372] Figure 12d The widening process is shown in detail:

[0373] 1) Perspective view of the straight bone tunnel 4;

[0374] 2) Perspective view of the straight bone tunnel 4 with a first widened section 5 milled using the cracking systems 400, 500 of the present invention; and

[0375] 3) Perspective view of the straight bone tunnel 4 with a first widened section 5 and a second widened section 6 milled using one of the cracking systems 400, 500 of the present invention.

[0376] In a specific example of reconstructing the anterior cruciate ligament, the intra-articular outlet of the bone tunnel to be created must be able to insert fibrous material. In Caucasians, the thickness of the fibrous material is typically 2 to 4 mm and the width is typically 12 to 18 mm. However, the specific measurement ranges provided in the foregoing example must be adjusted according to the specific anatomy of other populations, the specific anatomy of a particular patient, the type and / or technique of the implant used, and / or the final application of the cracking tool in medicine or veterinary medicine.

[0377] Figure 12e A full view showing the steps of a method for repairing the anterior cruciate ligament (ACL) of the right knee is shown. Specifically, step 1 shows a full view of the joint, where the bone tunnel has been anatomically widened by the bilateral cracking tool 100 of the present invention. Step 2 shows the sutures pulling two branches of the quadruple semitendinosus tendon graft 500 into the tibial bone tunnel. Step 3 shows a full view of introducing the sutures at the femoral end of the implant into the femoral bone tunnel. Step 4 shows the anatomical twisting of the two branches of the implant.

[0378] In a specific embodiment, the fixation of the femoral end of the quadruple implant 40 is performed by a fixation ring cortical button, while the fixation of the sutures at the two tibial ends of the hanging graft is performed by retaining the sutures corresponding to each branch of the graft on both sides of the cortical fixation device 10, such as the device described in European Patent Application EP3897455 A1.

[0379] Figure 13a The configuration of the quadruple implant 40 of the semitendinosus tendon graft (ST) for repairing the ACL is shown.

[0380] In a particular embodiment (not shown in the figures), a small rigid cannula is used through the suture such that the pulling force exerted by the suture on the folded ends of the implant is evenly distributed, which facilitates introducing these folded ends into the widened sections of the corresponding bone tunnels created by the rupture systems 400, 500 of the present invention.

[0381] Figure 13b A configuration of an implant for ACL repair is shown, which has two branches from a hamstring allograft 41.

[0382] FIG. 13c shows an implant configuration having two branches from a quadriceps tendon graft 42, which configuration includes a bone plug for reconstructing the anterior cruciate ligament (ACL).

Claims

1. A bilateral rupture tool (100) for minimally invasive surgery, comprising: · A longitudinal element (120) oriented according to a main longitudinal axis (101), which further comprises: o A first longitudinal body (121) for linear movement along the main longitudinal axis (101) and comprising a first distal end (121.2), o A second longitudinal body (122) arranged parallel to the first longitudinal body (121), configured to perform linear movement along the main longitudinal axis (101) and comprising a second distal end (122.2); · A rupture assembly, which further comprises: o A rupture element (130) having a rupture axis (131) and configured to receive and perform a rupture movement about the rupture axis (131) and perform an angular movement to form a plurality of angles α with respect to the main longitudinal axis (101) contained in a main plane (101'), the main plane (101') containing the main longitudinal axis (101) and the rupture axis (131); and o A motion transmission element (140) comprising a distal portion (140.1), wherein the motion transmission element (140) has the following characteristics: It is arranged inside the longitudinal element (120), between the first longitudinal body (121) and the second longitudinal body (122); connected to the rupture element (130) through the distal portion (140.1), and configured to receive and perform a rupture movement and transmit the rupture movement to the rupture element (130); · A hinge connection device (150), which further comprises: o A first section (150.1) connected to the first distal end (121.2) of the first longitudinal body (121); o A second section (150.2) connected to the second distal end (122.2) of the second longitudinal body (122); and o A central section (151) including a through hole (151.1), through which the rupture assembly passes, and the rupture assembly is fixed inside the through hole (151.1); wherein the hinge connection device (150) is configured to perform an angular movement within the main plane (101') of the bilateral rupture tool (100) such that: When the first longitudinal body (121) performs linear movement in the proximal - distal direction, the second longitudinal body (122) performs linear movement in the distal - proximal direction, and the rupture element (130) performs an angular movement in the first direction within the main plane (101'), and When the first longitudinal body (121) performs linear movement in the distal - proximal direction, the second longitudinal body (122) performs linear movement in the proximal - distal direction, and the rupture element (130) performs an angular movement in a direction opposite to the first direction within the main plane (101').

2. The bilateral rupture tool (100) according to claim 1, wherein, The rupture assembly passes through the through hole (151.1) and is fixed inside the through hole (151.1) in the following ways: By the rupture element (130); or By the motion transmission element (140); or Partially through the rupture element (130) and partially through the motion transfer element (140); or Through a bearing installed in the through-hole (151.1); or By a combination of two or more of the above methods.

3. The bilateral rupture tool (100) according to claim 1 or 2, wherein, The motion transfer element (140) and / or the rupture element (130) is tubular.

4. The bilateral rupture tool (100) according to any one of claims 1-3, further comprising at least a first connection coupling device (160) configured to connect and / or couple the motion transfer element (140) to the rupture motion generating device (200, 200').

5. The bilateral rupture tool (100) according to any one of claims 1-4, further comprising A support body (110) that at least partially surrounds the longitudinal element (120), and A second connection coupling device (170) configured to connect and / or couple the support body (110) to the rupture motion generating device (200, 200').

6. The bilateral rupture tool (100) according to any one of claims 1-5, further comprising a rupture guide (300) configured to guide the longitudinal element (120) from an original position to at least one target position, wherein the rupture guide (300) comprises:[[]] A tubular guide (310), comprising:[[]] A longitudinal conduit (311) having a third proximal end (311.1) and a third distal end (311.2); the longitudinal conduit (311) includes a distal appendage (311.3) at the third distal end (311.2); and A striking edge (312) which is an extension of the longitudinal conduit (311) at the third proximal end (311.1); Wherein, the longitudinal conduit (311) is configured to accommodate the longitudinal element (120), the tubular guide (310) is oriented according to a first longitudinal guide axis (301); the striking edge (323) is configured to receive a striking force along the direction of the first longitudinal guide axis (301); and A guide arch (320), comprising:[[]] A proximal arcuate portion (321) including a first coupling device (330) configured to firmly connect and disconnect the proximal arcuate portion (321) relative to the tubular guide (310) at a plurality of different positions along the tubular guide (310), A distal arcuate portion (322) including a distal tip (322.1) and a distal point (322.2), the first longitudinal guide axis (301) passing through the distal arcuate portion (322); and A second coupling device (340) configured to connect and disconnect the distal arcuate portion (322) relative to the proximal arcuate portion (321) at a plurality of different positions, such that starting from a first position where the tubular guide (320) is oriented according to the first longitudinal guide axis (301), when the second coupling device (340) is in a position other than the first position according to the second longitudinal guide axis (301.1), it forms an angle β with the first longitudinal guide axis (301).

7. The bilateral rupture tool (100) according to claim 6, wherein, The tubular guide (310) further includes a first longitudinal hole (313) and a second longitudinal hole (313'); The first longitudinal body (121) further includes a first protrusion (121.3), and The second longitudinal body (122) further includes a second protrusion (122.3); wherein, the size of the first longitudinal hole (313) is adapted to receive and guide the first protrusion (121.3) from a proximal position to a distal position, and vice versa; and the size of the second longitudinal hole (313') is adapted to receive and guide the second protrusion (122.3) from a proximal position to a distal position, and vice versa.

8. The bilateral rupture tool (100) according to any one of claims 6 or 7, wherein, The distal appendage (311.3) includes: a triangular lobe tip; or two tips; or a beveled groove; or a surface of a polyhedron.

9. The bilateral rupture tool (100) according to any one of claims 1-8, further comprising an actuator (180, 190), the actuator being configured to generate a linear motion and transmit it to the first longitudinal body (121) and the second longitudinal body (122), such that the first longitudinal body 121 and the second longitudinal body 122 linearly move in opposite directions.

10. The bilateral rupture tool (100) according to claim 9, wherein: The first longitudinal body (121) includes a first longitudinal notch (121.4) configured to cooperate with the actuator (180); and The second longitudinal body (122) includes a second longitudinal notch (122.4) configured to cooperate with the actuator (180); wherein, the actuator (180) includes: a first rod (181), configured to penetrate and cooperate with the first longitudinal notch (121.4); a second rod (182), configured to penetrate and cooperate with the second longitudinal notch (122.4); and a trigger (180.1) connected to the first rod (181); wherein, the first rod (181) and the second rod (182) are arranged in parallel and are interconnected by two longitudinal portions (183, 184) at their ends, such that: when the trigger (180.1) rotates relative to a rotation axis (185) located between the first rod (181) and the second rod (182) in the proximal-distal direction, the first rod (181) rotates in the proximal-distal direction, driving the first longitudinal body (121) to perform a proximal-distal linear motion; the second rod (182) rotates in the distal-proximal direction, driving the second longitudinal body (122) to perform a distal-proximal linear motion; when the trigger (180.1) rotates relative to the rotation axis (185) in the distal-proximal direction, the first rod (181) rotates in the distal-proximal direction, driving the first longitudinal body (121) to perform a distal-proximal linear motion; the second rod (182) rotates in the proximal-distal direction, driving the second longitudinal body (122) to perform a proximal-distal linear motion.

11. The bilateral rupture tool (100) according to claim 10, further comprising positioning and fixing means for the actuator (180), Among them, The positioning and fixing device of the actuator (180) is configured to position and fix the actuator (180) at a plurality of different positions such that for each of said positions, the distance between the first distal end (121.1) of the first longitudinal body (121) and the second distal end (122.1) of the second longitudinal body (122) is different.

12. The bilateral rupture tool (100) according to any one of claims 9-11, wherein, The actuator (180, 190) further includes a return spring configured to apply a return force to the first longitudinal body (121) and the second longitudinal body (122) such that the relative movement between the first longitudinal body (121) and the second longitudinal body (122) is substantially zero.

13. The bilateral rupture tool (100) according to claim 9, wherein: The first longitudinal body (121) includes a first external thread (191) configured to cooperate with the actuator (190); and The second longitudinal body (122) includes a second external thread (192) configured to cooperate with the actuator (190); wherein, the thread directions of the first external thread (191) and the second external thread (192) are opposite; wherein, the actuator (190) includes a nut (193), which includes: a first internal thread portion (193.1) that mates with the first external thread (191); and a second internal thread portion (193.2) that mates with the second external thread (192); wherein, the thread directions of the first internal thread portion (193.1) and the second internal thread portion (193.1) are opposite, and the nut (193) is configured to cooperate with the first longitudinal body (121) and the second longitudinal body (122) such that the assembly operates in a manner similar to a dual-spindle mechanism; an actuator controller (194) connected to the nut (193); wherein, when the actuator controller (194) rotates in the thread direction of the first internal thread portion (193.1), the first longitudinal body (121) performs a proximal-distal linear movement, and the second longitudinal body (122) performs a distal-proximal linear movement; when the actuator controller (194) rotates in the thread direction of the second internal thread portion (193.1), the first longitudinal body (121) performs a distal-proximal linear movement, and the second longitudinal body (122) performs a proximal-distal linear movement.

14. The bilateral rupture tool (100) according to any one of claims 1-13 further includes a suction line that can be connected to an external suction device for removing tissue.

15. The bilateral rupture tool (100) according to any one of claims 1-14, wherein, The first longitudinal body (121) and / or the second longitudinal body (122) is rigid and / or straight.

16. A bilateral rupture system (400) for minimally invasive surgery, comprising: a rupture motion generating device (200) for generating and executing a rupture motion; at least one bilateral rupture tool (100) according to any one of claims 1-15, which is at least connectable to the rupture motion generating device (200) through the motion transmission element (140); wherein, the rupture motion generating device (200) is further configured to transmit the rupture motion to the motion transmission element (140).

17. A bilateral rupture system (500) for minimally invasive surgery, comprising: A rupture motion generating device (200'), configured to generate and execute a rupture motion; At least one bilateral rupture tool (100) according to any one of claims 5-15, which can be connected to the rupture motion generating device (200') through the motion transmission element (140) and the support body (110); wherein, The rupture motion generating device (200') is configured to transmit the rupture motion to the motion transmission element (140); and The rupture motion generating device (200') further includes actuators (180', 190'), which are configured to generate a linear motion and transmit it to the first longitudinal body (121) and the second longitudinal body (122), such that the first longitudinal body (121) and the second longitudinal body (122) linearly move in opposite directions after receiving the linear motion from the actuators (180', 190').

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